# K151465: AeroDR SYSTEM 2

- Pathway: 510(k) (Special)
- Applicant: Konica Minolta, Inc.
- Decided: Jun 29, 2015 after 28 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K981556 (1998). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141271: Aerodr System 2, Konica Minolta, Inc. (2014) Summary page 4.

## Most influential descendants
- K241319: SKR 3000 (2024), 1 descendant of its own
- K250665: SKR 3000 (2025), 0 descendants of its own

## Recalls of this device
- May 9, 2018 · Class II · Z-2281-2018: Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignition (fire) in CF-C2 "Toughbook" laptops. Since Konica Minolta uses this laptop in some of its product c

## Indications for use
The AeroDR SYSTEM 2 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpse diagnostic procedures. The AeroDR SYSTEM 2 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

Source page: https://510kreport.com/device/K151465
Methodology: https://510kreport.com/methodology